Prosecution Insights
Last updated: October 23, 2026
Application No. 18/451,579

IODINE LABELED HYDROGELS AND PRECURSORS THEREOF WITH IMPROVED PROPERTIES

Non-Final OA §103§112§DP
Filed
Aug 17, 2023
Priority
Aug 17, 2022 — provisional 63/398,756
Examiner
SAWYER, JENNIFER C
Art Unit
1691
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Boston Scientific Corporation
OA Round
1 (Non-Final)
68%
Grant Probability
Favorable
1-2
OA Rounds
0m
Est. Remaining
60%
With Interview

Examiner Intelligence

Grants 68% — above average
68%
Career Allowance Rate
386 granted / 564 resolved
+8.4% vs TC avg
Minimal -8% lift
Without
With
+-8.2%
Interview Lift
resolved cases with interview
Typical timeline
2y 9m
Avg Prosecution
51 currently pending
Career history
620
Total Applications
across all art units

Statute-Specific Performance

§101
0.6%
-39.4% vs TC avg
§103
49.0%
+9.0% vs TC avg
§102
13.5%
-26.5% vs TC avg
§112
26.7%
-13.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 564 resolved cases

Office Action

§103 §112 §DP
Notice of Pre-AIA or AIA Status The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . Detailed Action This office action is in response to applicant’s communication filed on 9/1/26. Claims 1-20 are pending in this application. Applicant's election of Group I, claims 1-17, without traverse, in the reply filed on 9/1/26 is acknowledged. Claims 18-20 are withdrawn from consideration being drawn to the non-elected invention. As a result, claims 1-17 are being examined in this Office Action. Priority The applicant claims benefit as follows: PNG media_image1.png 80 386 media_image1.png Greyscale Objections Claims 5 and 8 are objected to because of the following informalities: Claim 5 is objected to because of informal wording. Claim 5 recites “where the iodinated amino acid residue.” The word “where” appears to be a typographical error for “wherein.” Claim 8 is objected to because of informal wording. Claim 8 recites “x is 0, 1, 2 3, 4, 5 or 6.” A comma appears to be missing between “2” and “3.” Appropriate correction is required. Claim Rejections - 35 USC § 112 The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. Claims 12 and 16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. Claim 12 is indefinite because the claim recites “one or more hydrophilic monomers selected from ... or PNIPAAM.” The abbreviation “PNIPAAM” is not defined in the claims or in the specification. PNIPAAM is commonly used to mean poly(N-isopropylacrylamide), which is a polymer, not a monomer. Thus, it is unclear whether claim 12 requires the monomer N-isopropylacrylamide or the polymer poly(N-isopropylacrylamide). The metes and bounds of claim 12 are unclear. Claim 16 is indefinite because the claim recites that “the accelerant composition is provided in a syringe barrel.” Claim 16 depends from claim 15, which recites “an optional accelerant composition.” Thus, it is unclear whether claim 16 requires the accelerant composition, or only requires that the accelerant composition, if present, be provided in a syringe barrel. The metes and bounds of claim 16 are unclear. Appropriate correction is required. Claim Rejections – 35 USC 103 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. Claims 1 and 12-17 are rejected under 35 U.S.C. 103 as being unpatentable over Campbell et al. (US 20110142936, pub date Jun. 16, 2011, in applicant’s IDS filed 10/25/23). Determination of the Scope and Content of the Prior Art (MPEP §2141.01) Campbell et al. teaches hydrogels made from precursors that covalently crosslink with each other. Campbell et al. teaches that each precursor may have only nucleophilic groups, such as amines, or only electrophilic groups, such as N-hydroxysuccinimide (NHS) esters, so long as both types of precursors are used. Campbell et al. further teaches that at least one precursor has three or more functional groups, so that the precursors form a crosslinked network. (Campbell et al., paragraphs [0032], [0039]-[0040], [0058]) Campbell et al. teaches multi-armed precursors having hydrophilic polyethylene glycol (PEG) arms, for example 4 to 16 arms. Campbell et al. teaches PEG arms that end in succinimidyl glutarate (SG) or succinimidyl succinate (SS) groups. Campbell et al. teaches that SG and SS are succinimidyl esters that have an ester group that degrades by hydrolysis. Campbell et al. further teaches that NHS esters are useful for crosslinking amine-containing polymers. (Campbell et al., paragraphs [0041], [0047], [0054], [0056]-[0057], [0084]) Campbell et al. teaches amine precursors, such as trilysine and amine-terminated multi-arm PEG. Campbell et al. teaches a hydrogel formed from a multi-armed PEG reacted with trilysine. (Campbell et al., paragraphs [0044], [0048], [0054], [0058], [0138]) Campbell et al. teaches radiopaque (RO) agents covalently attached to a precursor. In the examples, an 8-arm PEG has some arms bound to triiodobenzoate (TIB) and the other arms end in SG groups. This iodinated PEG is crosslinked with trilysine. Campbell et al. further teaches that the precursors set forth “may be decorated with one or more RO agents,” and that “[i]n the case of a branched or multi-functional precursor, one or more of the available reactive sites may be left unreacted.” Campbell et al. teaches RO agents such as TIB, 2,3,5-triiodobenzoic acid, and 3,4,5-triiodophenol. (Campbell et al., paragraphs [0077], [0080]-[0081]) Campbell et al. also teaches that the TIB groups placed on the PEG take the place of SG arms. Campbell et al. teaches that gels with more TIB arms, and thus fewer SG linkages, moved toward complete hydrolysis faster. (Campbell et al., paragraphs [0080]-[0081]) Campbell et al. teaches a branched polymer with succinimidyl ends and a low molecular weight nucleophilic precursor in a low pH (4.0) diluent, which is activated by a higher pH (8.8) solution. Campbell et al. teaches that NHS solutions are best made just before crosslinking, because NHS groups react with water. Campbell et al. further teaches kits and systems with syringes, a double-barreled applicator, a syringe that holds an activator, and containers such as a syringe barrel or a vial with a septum. (Campbell et al., paragraphs [0023], [0057], [0075], [0128]-[0129], [0131]-[0132], [0134]) Ascertainment of the Difference Between Scope the Prior Art and the Claims (MPEP §2141.012) Campbell et al. teaches the claimed reactive multi-arm polymer and an amine crosslinker such as trilysine. However, Campbell et al. is deficient in the sense that its examples attach the iodinated RO agent to the multi-arm PEG, and not to the amine precursor. Thus, Campbell et al. does not expressly exemplify an iodinated polyamino compound as recited in claim 1. Finding of Prima Facie Obviousness Rationale and Motivation (MPEP §2142-2143) However, it would be prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to attach Campbell et al.’s RO agent, such as TIB, to Campbell et al.’s amine precursor, such as trilysine, and to crosslink the resulting iodinated amine precursor with Campbell et al.’s SG-terminated multi-arm PEG. Campbell et al. expressly teaches that its precursors may be decorated with RO agents while other reactive sites are left unreacted. Trilysine is one of these precursors. Trilysine has four amino groups. Attaching one TIB group to trilysine leaves three amino groups, which Campbell et al. teaches is enough to form a crosslinked network. The product is an iodinated polyamino compound as claimed. (Campbell et al., paragraphs [0039], [0054], [0081]) Campbell et al. teaches only two types of precursors, nucleophilic and electrophilic. Placing the RO agent on the nucleophilic precursor, rather than on the electrophilic precursor, is a choice from a finite number of identified, predictable solutions. One of ordinary skill in the art would also have been motivated to make this choice, because Campbell et al. teaches that each TIB group on the PEG takes the place of an SG crosslinking arm, and that gels with fewer SG linkages hydrolyze faster. Placing the iodine on the amine precursor keeps all of the PEG arms free to crosslink. There would have been a reasonable expectation of success, because Campbell et al. teaches that an amine reacts with a carboxylic acid to form an amide bond, and TIB is a carboxylic acid. (Campbell et al., paragraphs [0034], [0080]-[0081]) With regard to claim 12, Campbell et al. teaches PEG arms, which are made of ethylene oxide units. (Campbell et al., paragraphs [0041], [0054]) With regard to claims 13-14, Campbell et al. teaches SG and SS end groups. These are succinimidyl (imide) esters, which are electrophilic groups. Campbell et al. teaches that these groups have an ester group that degrades by hydrolysis. Thus, Campbell et al. teaches reactive end groups that are linked to the arms by a hydrolysable ester and that are imide esters. (Campbell et al., paragraphs [0054], [0056]-[0057], [0062], [0084]) With regard to claim 15, Campbell et al. teaches that each precursor may be held in its own syringe, and that the precursors form a matrix upon mixing. Campbell et al. further teaches a higher pH solution that activates crosslinking. Thus, a first precursor composition that comprises the iodinated polyamino compound, a second precursor composition that comprises the multi-arm polymer, and an accelerant composition would have been obvious. (Campbell et al., paragraphs [0075], [0132]) With regard to claim 16, Campbell et al. teaches a low pH diluent that holds the small amine precursor, a higher pH activating solution, kits with syringes, a syringe that holds an activator, and a vial with a septum as a known container. Campbell et al. also teaches that NHS solutions are best made just before use, because NHS groups react with water. Thus, it would have been obvious to provide the amine precursor solution in a syringe barrel, to store the NHS-ester PEG in a vial until use, and to provide the higher pH accelerant in a syringe barrel. The choice of which known container holds which known composition is an obvious matter of design choice, absent evidence of unexpected results. (Campbell et al., paragraphs [0057], [0075], [0131]-[0132], [0134]) With regard to claim 17, Campbell et al. teaches delivery devices, such as a double-barreled applicator, two syringes attached to a Y-connector with a static mixer, and a catheter. (Campbell et al., paragraphs [0023], [0128]-[0129], [0132]) Claims 2-11 are rejected under 35 U.S.C. 103 as being unpatentable over Campbell et al. (US 20110142936, pub date Jun. 16, 2011, in applicant’s IDS filed 10/25/23), in view of Lim et al. (WO 2018020262, pub date Feb. 1, 2018). Determination of the Scope and Content of the Prior Art (MPEP §2141.01) As discussed above, Campbell et al. teaches a hydrogel system with an SG-terminated multi-arm PEG and a trilysine crosslinker. Campbell et al. teaches that its precursors, including trilysine, may be decorated with RO agents while other reactive sites are left free to crosslink. Campbell et al. further teaches that an amine reacts with a carboxylic acid to form an amide or peptide bond. (Campbell et al., paragraphs [0034], [0054], [0080]-[0081], [0138]) Lim et al. teaches radiopaque compounds comprising diiodotyrosine (DIT). Lim et al. teaches that DIT is the amino acid tyrosine, or its residue, substituted on the phenyl ring with two iodine atoms. Lim et al. shows 3,5-diiodotyrosine, which has a phenyl ring bearing two iodine atoms and one hydroxyl group, and which has a carboxylic acid group. (Lim et al., page 3, lines 13-20; page 4, lines 1-2) Lim et al. teaches radiopaque compounds that are peptides comprising at least one DIT. Lim et al. teaches DIT-containing peptides such as (K’Y’)m, in which DIT (’Y’) is next to lysine (K). Lim et al. teaches that DIT is suitably next to a lysine residue. (Lim et al., page 5, lines 17-18; page 7, lines 3-6; page 24, lines 15-19) Lim et al. teaches that DIT is joined into peptides by standard Fmoc solid-phase peptide synthesis, that is, by amide (peptide) bond formation. (Lim et al., page 27, lines 1-25) Lim et al. further teaches that lysine-rich DIT peptides have good aqueous solubility, and that adding one lysine residue for each DIT gives excellent solubility. Lim et al. teaches that DIT peptides are visible by X-ray imaging. (Lim et al., abstract; page 37, Table 1, entries 20-23; page 38, lines 1-4 and 23-34) Ascertainment of the Difference Between Scope the Prior Art and the Claims (MPEP §2141.012) Campbell et al. teaches TIB as an RO agent. However, Campbell et al. is deficient in the sense that it does not teach an iodinated amino acid residue, such as DIT, linked to the polyamino moiety by an amide group, as recited in claims 2-7. Campbell et al. also does not expressly teach the specific iodinated trilysine structure recited in claims 8-11. Lim et al. cures this deficiency. Lim et al. teaches DIT as a radiopaque amino acid. Lim et al. teaches that DIT is joined to lysine residues by standard amide (peptide) bonds, and that lysine next to DIT improves solubility. (Lim et al., page 7, lines 3-6; page 27, lines 1-25; page 38, lines 23-34) Finding of Prima Facie Obviousness Rationale and Motivation (MPEP §2142-2143) Therefore, it would be prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use Lim et al.’s DIT as the RO agent on Campbell et al.’s trilysine crosslinker, by forming an amide (peptide) bond between the carboxyl group of trilysine and the amino group of DIT. This gives a lysine-DIT peptide, such as Lys-Lys-Lys-DIT. Both TIB and DIT are known iodinated aromatic groups used to make a compound radiopaque. Replacing one known radiopaque group with another for the same purpose is a simple substitution that yields predictable results. One of ordinary skill in the art would have been motivated to use DIT because Lim et al. teaches that DIT is a naturally occurring, radiopaque amino acid that is readily joined to lysine by standard peptide coupling, and that lysine next to DIT improves water solubility. There would have been a reasonable expectation of success, because both Campbell et al. and Lim et al. teach standard amide bond formation between an amine and a carboxylic acid. (Campbell et al., paragraph [0034]; Lim et al., page 27, lines 1-25; page 38, lines 23-34) With regard to claims 2, 3 and 6, the lysine-DIT peptide has a trilysine residue (a polyamino moiety) linked by an amide group to a DIT residue. The DIT residue has an iodinated aromatic group and a carboxylic acid group. Thus, the DIT residue is a carboxy-substituted iodinated moiety as claimed. With regard to claims 4-5, DIT is an iodinated amino acid, and its residue comprises an iodinated aromatic group, namely a diiodophenyl group. (Lim et al., page 3, lines 13-20) With regard to claim 7, the DIT aromatic group is a monocyclic phenyl ring substituted with two iodine groups and one hydroxyl group. (Lim et al., page 3, lines 13-20) With regard to claims 8-9, the trilysine residue has lysine side chains, each ending in a –(CH2)4–NH2 group, where x is 4. These groups are disposed along a peptide of three lysine residues, which is a polymeric moiety. With regard to claim 10, trilysine has a carboxyl group and a plurality of amino groups. Thus, trilysine is a carboxyl-substituted polyamino compound, and the lysine-DIT peptide comprises its residue. With regard to claim 11, the trilysine residue comprises three lysine residues. Note that an express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982). The use of DIT in place of TIB represents a predictable substitution of one known radiopaque iodinated group for another. Double Patenting The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the "right to exclude" granted by a patent and to prevent possible harassment by multiple assignees. See In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.130(b). Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b). The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp. Claims 1-17 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-13 and 21-27 of copending Application No. 17972007 (issued on 9/16/26, but no patent number assigned yet), in view of Lim et al. (WO 2018020262, pub date Feb. 1, 2018), and further in view of Campbell et al. (US 20110142936, pub date Jun. 16, 2011, in applicant’s IDS filed 10/25/23). The teachings of Lim et al. and Campbell et al. have been discussed above. The instant claims are directed to a system for forming a hydrogel that comprises an iodinated polyamino compound and a reactive multi-arm polymer having hydrophilic polymer arms with reactive end groups that react with the amino groups of the iodinated polyamino compound. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of copending Application No. 17/972,007 are directed to a system for forming a hydrogel that comprises a first composition comprising a polyiodinated polyamino compound and a second composition comprising a reactive multi-arm polymer having hydrophilic polymer arms with reactive end groups that react with the amino groups of the polyiodinated polyamino compound. The polyiodinated polyamino compound of the copending claims is a species of the iodinated polyamino compound of instant claim 1. Thus, instant claims 1 and 15 are anticipated by copending claim 1. The accelerant of instant claim 15 is optional. The iodinated moiety limitations of instant claims 2-6 are also not patentably distinct. The copending claims recite a polyamino moiety linked by an amide group to a core, wherein the core is a residue of a polycarboxylate amino compound, such as L-glutamyl-L-glutamic acid, triglutamic acid, or N2,N2-bis(carboxymethyl)lysine, and wherein iodinated aromatic moieties are each linked to the core by an amide group. The core and its iodinated aromatic groups form an iodinated amino acid residue, which has iodinated aromatic groups and carboxylate (amide) groups. Applicant’s specification states that carboxylate groups include carboxylate amide groups, and defines an iodinated amino acid as an amino acid whose side group contains one or more iodine atoms. Thus, the copending core with its iodinated aromatic groups is a carboxy-substituted iodinated moiety and an iodinated amino acid residue, as recited in instant claims 2-6. (copending claims 1, 4-6 and 21-23; Specification, paragraphs [0038] and [0041]) Reference to applicant’s specification refers to applicant’s PGPub: US 20240076266. The polyamino moiety limitations of instant claims 8-11 are likewise not patentably distinct. The copending claims recite a residue of a lysine oligomer, specifically a trilysine residue. Trilysine is a carboxyl-substituted polyamino compound with three lysine residues, and its –(CH2)4–NH2 side chains are disposed along a polymeric moiety. (copending claims 2-3) The arm, end group, and device limitations of instant claims 12-14 and 17 are recited in the copending claims, namely the same hydrophilic monomers, a hydrolysable ester link, electrophilic imide ester end groups such as N-hydroxysuccinimidyl esters, and a delivery device. (copending claims 7-9, 11, 24 and 26-27) To the extent instant claim 7 recites an iodinated aromatic group substituted with one or more hydroxyl groups, copending claim 5 recites iodinated aromatic moieties substituted with iodine groups and C1-C4-hydroxyalkyl groups. Lim et al. teaches DIT, an iodinated amino acid with a hydroxyl group on its diiodophenyl ring, as a radiopaque group that is readily joined to lysine by amide bonds and that gives good solubility together with lysine. Thus, it would have been obvious to use DIT as the iodinated amino acid residue in the copending system. (Lim et al., page 3, lines 13-20; page 7, lines 3-6; page 38, lines 23-34) To the extent instant claim 16 recites a syringe barrel, a vial, and an accelerant composition, copending claim 13 recites syringe barrels. Campbell et al. teaches a low pH amine precursor solution, a higher pH activating solution, syringes, and a vial as a known container, as discussed above. Thus, claim 16 would have been an obvious packaging choice. (Campbell et al., paragraphs [0057], [0075], [0131]-[0132], [0134]) Accordingly, instant claims 1-17 are not patentably distinct from claims 1-13 and 21-27 of copending Application No. 17972007, in view of Lim et al. and Campbell et al. Claims 1-17 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-20 of copending Application No. 18103932, in view of Lim et al. (WO 2018020262, pub date Feb. 1, 2018), and further in view of Campbell et al. (US 20110142936, pub date Jun. 16, 2011, in applicant’s IDS filed 10/25/23). The teachings of Lim et al. and Campbell et al. have been discussed above in this office action. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of copending Application No. 18103932 are directed to a system for forming a hydrogel that comprises a first composition comprising a polyiodinated polyamino compound, in which a polyamino moiety is linked to a polyiodinated aromatic moiety by an amide group, and a second composition comprising a reactive multi-arm polymer having hydrophilic polymer arms with reactive end groups that react with the amino groups of the polyiodinated polyamino compound. The polyiodinated polyamino compound of the copending claims is a species of the iodinated polyamino compound of instant claim 1. Thus, instant claims 1 and 15 are anticipated by copending claim 1. The polyamino moiety limitations of instant claims 8-11 are not patentably distinct. The copending claims recite a residue of a carboxyl-substituted polyamino compound, such as a polylysine compound, and a plurality of –(CH2)x–NH2 groups, where x is 0 to 6, disposed along a polymeric moiety. A polylysine compound comprises two or more lysine residues. (copending claims 7-10) The arm, end group, and device limitations of instant claims 12-14 and 17 are recited in the copending claims. (copending claims 11-14) To the extent instant claims 2-7 recite a carboxy-substituted iodinated moiety that is an iodinated amino acid residue having a hydroxyl-substituted iodinated aromatic group, the copending claims recite that the polyiodinated aromatic moiety is a residue of an amino-substituted polyiodinated aromatic compound linked to the polyamino moiety by an amide group. Lim et al. teaches DIT, an amino-substituted, diiodinated aromatic amino acid that has a carboxylic acid group and a hydroxyl group on its phenyl ring. Lim et al. teaches that DIT is radiopaque, that DIT is readily joined to lysine by amide bonds, and that lysine next to DIT improves solubility. Thus, it would have been obvious to use DIT as the amino-substituted polyiodinated aromatic compound of the copending claims. (copending claims 1-3; Lim et al., page 3, lines 13-20; page 7, lines 3-6; page 27, lines 1-25; page 38, lines 23-34) To the extent instant claim 16 recites a syringe barrel, a vial, and an accelerant composition, copending claim 16 recites syringe barrels. Campbell et al. teaches a low pH amine precursor solution, a higher pH activating solution, syringes, and a vial as a known container, as discussed above. Thus, claim 16 would have been an obvious packaging choice. (Campbell et al., paragraphs [0057], [0075], [0131]-[0132], [0134]) Accordingly, instant claims 1-17 are not patentably distinct from claims 1-20 of copending Application No. 18103932, in view of Lim et al. and Campbell et al. This is a provisional obviousness-type double patenting rejection, because the conflicting claims have not in fact been patented. Conclusion No claim is allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jennifer Cho Sawyer whose telephone number is (571) 270 1690. The examiner can normally be reached on Monday-Friday 9 AM - 6 PM PST. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Renee Claytor can be reached on (571) 272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-274-1690. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /JENNIFER C SAWYER/Examiner, Art Unit 1691 /RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691
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Prosecution Timeline

Aug 17, 2023
Application Filed
Oct 01, 2026
Non-Final Rejection mailed — §103, §112, §DP (current)

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Prosecution Projections

1-2
Expected OA Rounds
68%
Grant Probability
60%
With Interview (-8.2%)
2y 9m (~0m remaining)
Median Time to Grant
Low
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